Medical Regulatory Authority Germany

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BfArM - Homepage

https://www.bfarm.de/EN/Home/_node.html

The BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency (EMA), …

The Federal Ministry of Health

https://www.bundesgesundheitsministerium.de/en/ministry/the-federal-ministry-of-health.html

The Federal Ministry of Health The Federal Ministry of Health is responsible for a variety of policy areas, whereby its activities focus predominantly on the drafting of …

BfArM - Placing medical devices on the market

https://www.bfarm.de/EN/Medical-devices/Overview/Regulatory-framework/Placing-medical-devices-on-the-market/_node.html

Regulatory framework Laws and ordinances Institutions Europe and EUDAMED Tasks of the BfArM Clinical investigations and performance studies Risk assessment …

National competent authorities (human) | European …

https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human

List of national competent authorities in the EEA. Information on coronavirus …

The Essential List of Regulatory Authorities …

https://www.raps.org/news-and-articles/news-articles/2020/1/the-essential-list-of-regulatory-authorities-in-eu

To ease the process of finding drug and medical device regulators in Europe, Focus has updated …

Q&A: pharma & medical device regulation in Germany

https://www.lexology.com/library/detail.aspx?g=4e521a96-5e31-43f8-a45e-e4d080d32452

In Germany, medicinal products must be approved by the relevant higher federal authority (BfArM or PEI, depending on the drug). This approval is required in …

Global Regulatory Authority Websites - PDA

https://www.pda.org/scientific-and-regulatory-affairs/regulatory-resources/global-regulatory-authority-websites

Germany: Paul Ehrlich Institute (in German) Germany: Federal Institute for Risk Assessment (in German) Germany: Ministry of Consumer Protection, Food and Agriculture (in …

Medical Device Regulations in Germany

https://www.regdesk.co/reg-ger/

Since Germany is a European Union member country, it follows the device classification system that of EU Medical Device Directives (MDD) soon to be replaced by …

Medical Device Registration in Germany - Thema Med

https://www.thema-med.com/en/medical-device-registration-in-germany/

Medical Device Registration in Germany. All Medical Devices must bear the CE marking in order to be marketed. Non-EU Manufacturers must appoint an Authorized European …

Medical device registration Germany, Notification, …

https://medicaldevices.freyrsolutions.com/medical-devices-regulatory-services-germany

The German Medical Device industry is known for producing high-quality medical equipment. It is the world’s third-largest market and accounts for a huge amount of global …

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